We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.
About this consultation
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals.
The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway for biologicals in certain circumstances. This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time, where the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG).
All recent TGA consultations can be found at the TGA consultation hub.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.